Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019798
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NASACORT | TRIAMCINOLONE ACETONIDE | 0.055MG/INH | AEROSOL, METERED;NASAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/11/1991 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/17/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1997 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/02/1996 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/20/1996 | SUPPL-6 | Efficacy-New Indication |
Label is not available on this site. |
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| 11/21/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/06/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 11/30/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |